Respiratory Tract Infections Clinical Trial
Official title:
Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study
Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common
infections (gastrointestinal and respiratory) in healthy children who attend day care centre
This study is a prospective, randomized, double blind, placebo- controlled parallel study in
healthy children attending day care centers.
The study will investigate the effect of supplementation with the probiotic strain
Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and
respiratory infections and absence from day care due to infections.
The test product is a sachet containing 1 gram of powder. The test product will contain
minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is
an identical product except for the absence of probiotics.
The study includes 3 months (90 days) of intervention period. The study product will be
consumed daily in the evening together with a meal.
The consumption of the study products will be taken under the surveillance of the parents.
During the entire intervention period the subjects are not allowed to consume any probiotic
products other than the study products supplied to them by the study personnel.
Data on infections will be recorded in a diary, filled in and administered by the parents and
diary recorded by referring physician (on-call log).
All infections are to be diagnosed by the local physician. The incidence of infections will
be analyzed based on the information recorded in the diaries (parent's & physician's).
n/a
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